Hearing on Swindlers, Hucksters and Snake Oil Salesmen:
The Hype and Hope of Marketing Anti-Aging Products to Seniors
September 10, 2001

Introduction

Thank you Mr. Chairman.

Indeed it is an honor, and I am delighted, to have been asked
to speak with you today about this most important topic. Having
come from a very small town, which I would define as a place where
my parents would know the make-up, dress, and decorum of a date
with whom I went to the movies, before I got home, I never imagined
either being here, or doing many of the things I have done. I
have had many co-workers, colleagues, teachers, and assistants
along the way, and any credit due me is credit due, much more,
to them.

Yes, indeed, I did attend a bit of school. And even though
I have done many things in my professional life, let me say that
I am first and foremost a clinician. As is the case with most
of my professional colleagues, my aim is always to place the interests
of my patients first. Those interests, I emphasize, include the
notion that what we say to patients and our clinical methods be
backed by sound science. A correct diagnosis becomes the road
towards a treatment or cure, and is always supported by a consistent
history, physical findings, and objective tests. Conjecture, belief,
and unproven hypotheses have little place in clinical practice.
These rightly belong in the realm of research where adequate protection
for the rights and interests of patients have been put in place,
and are closely monitored.

Health care is one of the most important areas in anyone's
life. With the complexity of the human organism, and with the
specialized knowledge required to evaluate providers and methods,
regulatory agencies have been developed to license professionals
and the materials with which they work. Most practitioners are
honest, caring providers. For those who are not, the public requires
that its government provide protection from scams, con artists,
and other abusive practices; especially the use of ineffective
drugs, ineffective devices, dangerous materials, and dangerous
devices. The public also requires protection from unscrupulous
merchants who are driven by greed.

We enjoy one of the best medical care systems in the world.
This has not happened by accident. More than a century of diligent
work has made our system of evidence-based medical care, and I
use the term "medical care" in a most general sense,
the envy of most other countries. We have produced some truly
amazing capabilities--from artificial body parts to kidney dialysis;
from elimination of diseases by vaccination to organ transplants;
from mapping the human genome to powerful medications to controlling
severe mental illness; from curing some forms of cancer to making
parents of otherwise infertile couples; and the list continues,
and is quite long.

We have made lives longer, better and healthier. This has been
done with substantial support for scientific research from both
government and the private sector. While we may disagree on where
and how to spend our resources, there has been little disagreement
on what standards we should have. We demand objective, scientific,
evidence-based data collected from carefully drawn experiments
and clinical trials, which are then used to show that clinical
care and medicines used are sound, scientific, effective, not
harmful, and beneficial.

Our system is not perfect, by any means. Beyond our scientific
base we exist in an open democracy that has an economic system
founded in capitalism. As we all know, these elements can occasionally
conflict. Market, and political and societal forces can certainly
affect behavior, control mechanisms and methods of covering costs,
direct decision-making, and determine access to care. Resolving
these conflicts is the very essence of our government, and one
reason for our success is that we regularly review where we have
been and where we are going.

The rise of modern medicine and the sale and use of medicines
over witchcraft, shamanism, vitalism, folktales, anecdotes, wishful
thinking, and snake oil has not been easy, but has also not been
by accident. It has been the consequence of society's desire to
want health care to be reproducible, safe, and efficacious. The
only way to achieve these objectives has been to apply scientific
method to what we do, and to constantly examine our practices
against this standard.

While we are a people of many beliefs and understand the place
of beliefs in our society and in our lives, we readily understand
and accept that belief is not science. Modern medical care and
medicines are based on science, and demand that evidence be the
basis of our practices. There is still a place in medicine for
the art of practice, a bedside manner, and practical skills, but
the "foundation of the house" is, and will continue
to be, scientifically gathered evidence. As we all know, there
is absolutely a place for belief and religion as a complement
to what we do.

In recent years there has been a movement to undo the requirement
that evidence be the only standard by which medical care is judged
and governed. This movement has been proposed and advanced principally
by those who wish to profit from being freed from the requirements
of evidence. It has also been promoted by others who claim that
anything should be allowed, whether it has a rational basis or
not, and that "freedom in health care" or "health
freedom" is some kind of right, and an innate principle under
which charlatans, quacks, and unscientific and unqualified practitioners
can operate. These advocates want a system where "anything
goes" without any safeguards for either safety or effectiveness,
let alone the truth. To make things a bit worse, this movement
has been joined by pseudoscientific zealots, and has been embraced
by a growing number of profiteers.

Make no mistake, this apparently "innocent" movement,
which appears to bring the "free market' to health care,
is a major danger. The issue is not, as the promoters
contend, protecting the so called "medicine-pharmaceutical
company complex". The promoters and profiteers have put up
this "smoke screen" to obscure their real agenda, which
is to escape the reins of evidence and regulations so that they
can enrich themselves. Through a program of disinformation and
obfuscation these neo-snake-oil salespeople have begun to undermine
the foundation of our excellent system of care. They have begun
to succeed at substituting pseudoscience for science, anecdote
for evidence, and nonsense for substance. Quality, scientifically-based
health care is currently at risk. More than that, the reliability
of the health care you yourselves receive is in severe jeopardy.

I come here today to speak with you about this problem.

The promoters and profiteers have been very effective so far.
They have whittled away at regulatory mandates, they have blurred
the lines between science and nonsense, and they have begun to
advance legislation to further their goals. In their quest they
have used every classical "trick" in the proverbial
"book" to advance their agenda. They have used flawed
logic, engaged in clever usage and misapplications of terms, and
accused others of "conspiracy theories", and other bogeymen,
to suggest that some pharmaceutical company-medical establishment
cartel is trying to keep "them" from "saving money"
for the public by withholding treatments and methods which allegedly
"work", but can be done for very little money by medically
unqualified individuals. Nothing is further from factual reality.

In the popular media we are barraged by stories about secret
herbal folk remedies and tiny electrical devices which can cure
all diseases for "a fraction" of what "conventional
medical care" costs. We see ads and testimonials about how
wearing refrigerator strength magnets in our clothing will somehow
improve strength and endurance, or athletic performance. Despite
our widespread knowledge of medicinal plants and pharmaceuticals,
we are being asked to believe that vast bodies of knowledge have
somehow been "suppressed for years", allegedly to keep
profits high in the medical establishment and to restrict access
to care. Further, we are being asked to accept as legitimate "primary
care physicians", individuals who have unsupported theories
of disease that have to do with "life forces being mis-aligned",
imaginary parasites which inhabit our bodies, supposed derangements
of our vertebral columns which cannot be demonstrated, and alleged
unnamed "toxins" in our environment.

While it is one thing to discard something that is worn-out,
ineffective, or damaged, it is something else to suggest that
we discard science for conjecture and fanciful notions.

What kind of logic have we taught in our schools that would
lead one to believe that a vial of water to which a spec of material
had once been added and then diluted to the point where no trace
of the material was there contains some kind of magic healing
powers? What kind of logic would suggest that all the major diseases
(cancer, heart disease, diabetes, viral infections including AIDS)
are caused by imaginary parasites living in our bodies which harbor
mutant bacteria, and that a simple electrical oscillator can destroy
these organisms creating instant cures? What kind of logic would
indicate that unseen and undetectable energy fields flow around
our bodies and are somehow disrupted by what we eat, breathe,
and imbibe causing disease and disability?

Many of you are probably chuckling to yourselves about these
fanciful notions. However, recent legislation enacted in some
states would permit all of these to be legitimate health practices.
Supposedly these practitioners would have to obtain "informed
consent" and instruct the patient about the lack of evidence
that supports the proposed treatment or program. Can we safely
assume that the promoters of these illogical theories would be
completely and objectively honest with their patients? Can we
also assume that they would not use their positions as levers
to foist these on suggestible, naïve, or desperate patients,
or their families? Can we also assume that one could apply regulation
to something which, by its very definition, is undefinable? Even
though I was born in a small town I am not so naïve, and
no matter where you are from, I doubt you are as well.

While any of us may be the target of such purveying predators,
those who are most likely to be approached and duped by these
hucksters are more likely the elderly, the infirm, the chronically
ill, the desperate, and the downtrodden. After a person is in
their clutches, the promise of a simple cure often is unfulfilled,
but is indeed linked to the acquisition of a substantial profit
by the practitioner.

Let's now focus on some areas of concern where this Committee,
the Senate as a whole, and your colleagues in the House should
direct some scrutiny:

Redefinitions of the New Age

Experimentation disguised as patient care

Problems with enforcement

In the brief time I have to speak today I cannot elaborate
on all of these. I hope, with a few cogent examples, to give you
some idea of what is out there, and why it may be problematic.

Redefinitions of the New Age
Calling Something By A Name Doesn't Make It So

The world of science is not a closed club. One must merely
put forward evidence of a claim and have it judged on the "open
market" of ideas. The process is simple, open and available.
The rules are fair and evenly applied. Make your hypothesis, put
forward your evidence, publish your results, and let others judge
your methods, results and conclusions. If your evidence is good,
and your logic is sound, your hypothesis is accepted. If not,
then it should be withdrawn.

Instead of this widely accepted practice that has gone on for
thousands of years, we are seeing an increasing array of initiatives
to legitimize otherwise illegitimate practices and disciplines.
Legislatures are being asked to create licensing boards for practices
that lack a scientific basis. Regulatory agencies are being told
they cannot regulate drug substances if they are called something
other than drugs. So-called "supplements" are being
marketed and used as if they were drugs free of regulation. Words
such as "Complementary and Alternative Medicine" are
reinterpreted to cover any non-scientific idea and practice that
has not met the criteria I outlined above. The public is separated
only by clever language from effective regulation. And, worse
than that, the public is not effectively protected from catastrophic
problems. I doubt that is what Congress intended in the Dietary
Supplement Health and Education Act of 1994 (DSHEA). Already we
have seen numerous reports of deaths and severe disability due
to some of these so-called "food and dietary supplements",
ephedra and aristolochia just to name two that you may have heard
about. There are many more. These, and other dangerous compounds,
are widely sold in "health food" stores as "supplements",
or are ingredients in "herbal" and other remedies sold
under the same concept. Does simply calling something a "food
or dietary supplement" make it a true food, or even a supplement?
I don't think so. Somehow calling something a "traditional
Chinese medicine" implies it has been in use for centuries
and, because of that name alone, is somehow valid, safe, and effective.
The truth lies elsewhere. Let us not mince words. These substances
are being promoted as drugs, in the common everyday usage of that
term, clever language, creative terminology and nosological acrobatics,
not withstanding.

Let's turn to another example. To get to the National Institutes
of Health in Bethesda from DuPont Circle I can take a cab or the
Metro, I can walk or even ride a bicycle. These are true "alternative"
methods of travel. However, no matter how hard I wish, or whatever
I may choose to believe, I can't ride a magic carpet, or self-levitate
and fly to Bethesda. The "alternative" to scientific,
evidence-based medical practices is non-evidence based, non-scientific
nonsense. It is grossly wrong and frankly ridiculous to place
this collection of anecdotes, pseudo-science and conjecture called
"alternative medicine" on the same stage with the real
thing. Yet that is precisely what has been done by legislative
fiat on both the federal and state levels. This cannot and should
not continue.

For those who may not remember, perhaps a lesson in history
may be useful. In the decade before the Mayflower landing at Plymouth,
Massachusetts, a mathematician/astronomer named Galileo produced
evidence that the Earth was not the center of the solar system.
He validated the proposal of Copernicus that the planets moved
in orbits around the sun. As you might recall this went against
the prevailing "law" of his land and he was condemned
as a heretic and exiled. In those days the "law" was
from religious edict. It took many years, but the validity of
his data was confirmed. Today we would consider the notions that
the Earth is flat, or that the Sun revolves around the Earth as
without foundation. Our colleagues at NASA have given us ample
evidence that Galileo was correct.

The vindication of Galileo's ideas was not
merely a triumph of science over belief. Rather, the clash of
Galileo's theories and the existing "law" was evidence
that belief alone did not belong at the helm of the ship of state.
Indeed, our forefathers (and foremothers) fought to separate religious
belief from the state, embodied it in our Constitution, and that
has been one of our most important precepts and strengths.

Consider how the events of the early 1600's compare to the
issues to those of today. They are almost a case study in role
reversal.

Systems of health care based on "life forces", energy
fields, and unseen parasites are not science at all, and, at best,
are forms of "pseudo-religious" belief. Some of these
are obviously cults. Others are the products of delusions and
chicanery. No matter how they are packaged, these methods and
ideas are not science. Those who are trying to
legitimize this neo-vitalism through legislation are, in my opinion,
trying to legitimize a religion. Mind you I have no quarrel with
any religion. I only ask that a rose be labeled a member of the
genus Rosa., and that we follow the precepts of our Constitution.

In a book entitled, "The Cure for All Diseases",
a woman named Hulda Clark proclaimed that she had found by "research"
that "all diseases have simple explanations and cures once
their true cause (sic) is known." Clark claims a naturopathic
degree and maintains that a rare Asian liver fluke inhabits our
bodies and is triggered by "toxins" in the environment
to harbor mutant bacteria which cause all of our illnesses--diabetes,
high blood pressure, seizures, chronic fatigue syndrome, migraines,
Alzheimer's Disease, Parkinson's Disease , multiple sclerosis,
and AIDS. She further claims that inherited genetic diseases (e.g.
retinitis pigmentosa, Muscular Dystrophy) can be "disinherited."
All of this can be done with some simple electronic devices you
can build yourself with some parts from a local electronics store,
some remedies (including the dangerous material wormwood) which
are sold as "supplements", and some "cleanses"
by which you purge your gastrointestinal tract, liver and kidneys
to rid yourself of imaginary "gallstones" and "toxins".

Clark's books and products have produced millions of dollars
in revenue. A number of outlets, including ones that just happen
to be run by her son and her brother, hawk her recommended items
and sell the devices she claims cure "all diseases".
Based on even a cursory look, many of these items appear to be
illegal drugs and devices. Why then are they easy to find and
readily available for sale? I submit that the current laws are
difficult to adequately enforce, and that clever marketing and
some deliberate layering and nesting of sales entities make it
hard to find the true sellers and suppliers of these items.

While it might be argued that some of these items are "harmless"
since they really don't "do anything", I would like
to respectfully disagree, and illustrate this point by bringing
to the Committee's attention the story of a young woman with cancer
who followed the teachings of Hulda Clark "religiously":

My friend, Hanne, a young woman of 42 years, was diagnosed
with severe breast cancer. She got a full mastectomy and was
treated with chemo and radiation.

She contacted an alternative practitioner, who besides magnetic
treatments also deals with the Hulda Regehr Clark protocols.
These protocols are based on the idea that all cancers are caused
by a single internal parasite -- the human fluke.

Clark claims that all cancers are caused by "parasites,
toxins, and pollutants" and can be cured by killing the
parasites and ridding the body of environmental chemicals. "All
cancers are alike. They are all caused by a parasite. A single
parasite! If you kill this parasite, the cancer stops immediately.
The tissue becomes normal again. In order to get cancer, you
must have this parasite ...."

My friend started to follow the prescriptionsÖ for cleanses
and zapping in order to rid herself of the flukes.

The practitioner told her, that her beloved pets maybe were the
cause of her cancer by infecting her with the parasite! He urged
her to get the animals (5 dogs, 4 cats and birds) out of the
house. She managed to place all the animals with others, except
2 dogs, which were also treated with the zapper! I must tell
that she was single, and her pets were her whole life and heart.
She had a limited circle of friends, whom all have dogs, cats
and other animals. She therefore could not visit them, nor ask
them to visit her, because she was afraid of being re-infected!
Even her mother, who took care of her, could not bring her dogs,
they had to be placed with others too. She and her mother ended
up sitting very much alone - and THAT I find to be really cruel!
Taking away a terminal person's last joy of life, and placing
a false hope for full recovery.

She paid him at least $800 for capsules, tinctures, zappers.
She followed the protocol by the letter, ate organic food, and
changed her soap and hygiene articles to organic products.

After she had finished the chemo and radiation treatments, she
started to work again, but shortly ( year) after she was diagnosed
with a recurrence of the cancer, which had now spread to her
lungs and liver, in spite of what Hulda Clark claims!!

She again turned to the practitioner, who once again claimed
he could cure her, and he would now use a real strong cure! (She
received chemo at the same time.)

She said that [following the recommendations of] HC was her
only hope] consuming all those herbs and capsules, of which some
are known to be poisonous. They sure made her vomit a lot, and
spoiled her appetite! And thereby stole the good which proper
nutrition could have given her.

No matter what, she continued on the HC-protocol all by the letter.
She blindly trusted as "HC is a doctor and has written several
books, she must be sincere!"

One Friday she was taken to the hospital suffering from severe
lack of oxygen due to the cancer having spread to the lung tissue.
Tuesday I visited her, and watched her zapping, both her and
the dogs, and she swallowed a bunch of capsules.

Hanne died Monday night, Jan. 15, 2001.

God bless her soul.

[Written by Pia Johansen, Hanne's friend]

I would also pose a few simple questions to you. Do you honestly
believe that this alleged treatment is harmless? Can you properly
call this "Health Freedom" or is it Health Tyranny?

Pseudoscientific Experimentation Disguised as Patient
Care

In our society the public affords health practitioners an unusually
high status compared with some other countries. Also, in our society,
we have placed a high value on life. Consequently, people who
save lives provide healing, and ameliorate disease engender gratitude.
However, this status is not without a series of obligations. Knowing
people's most personal secrets and the complexities of their lives
carries with it the requirement of absolute confidentiality. Additionally,
there is the matter of trust. Health professionals are not merely
entrusted with the private information they come to know, but,
more importantly, are trusted with the very lives of their patients.
That is, one is expected to do what is proper, honest, safe, and
in the patient's best interests. This trust means that a practitioner
must be open, current, and careful, and is not allowed to deviate
from professional standards. These standards include the notion
that a practitioner neither experiments with his treatments nor
with the lives of his patients, unless there is a high potential
for a direct benefit to the patient, and the patient fully understands
what is being done, including all risks. A practitioner is also
entrusted to do no harm. The notion of doing no harm is extended
to include taking unknown risks without known benefit. Violation
of this trust undermines the very foundation of the health professions,
and, in my opinion is immoral.

It is problematic when practitioners advance their personal
ideas, often disguised as legitimate treatments, upon unsuspecting
patients for both real and fanciful illnesses. Beside the unsubstantiated
claims and methods promulgated by Hulda Clark, we regularly hear
about inappropriate use of hyperbaric oxygen, chelation therapy,
and conventional drugs, used for unapproved purposes, for allegedly
"treating" "poisonings", arteriosclerosis,
and cancer. We also hear about alleged diagnoses made by a litany
of pseudo scientific mumbo-jumbo including: applied kinesiology,
hair analysis, whole blood analysis, live cell analysis, and other
such nonsense. These alleged illnesses are "caused"
by environmental "toxins", dental "cavitations",
alleged mercury and heavy metal toxicity, NICO, and other made-up
conditions. Commonly we also hear of unapproved electrical devices
used in both the "diagnosis" and "treatment"
of these conditions.

So called "chelation therapy" is a case in point.
This concept has some appropriate uses in medicine, namely treatment
of acute metal poisonings with arsenic and lead. However it has
been contorted into something else by a number of practitioners.
These practitioners claim that they can "treat" calcified
atherosclerosis of the arteries of the heart and other organs
with this technique. Others claim to lower cholesterol and to
treat a number of serious illnesses such as rheumatoid arthritis.
Millions of dollars in payments are collected for this procedure.
The evidence would suggest it is a giant scam. In an attempt to
make what they do appear legitimate, some practitioners have even
suggested they are participating in a "study" and have
the patients sign "consent forms" for this illegitimate
treatment.

Among the most essential ions in our bodies is calcium. It
is absolutely necessary for the clotting of blood and muscle contraction.
Significant changes in serum calcium levels can be fatal. Thus,
applying any chelating agent that is attracted to divalent cations
must be done with great care and caution.

E.D.T.A.(EDTA) stands for ethylenediamine tetraacetic acid.
There are legitimate medical uses for some forms of EDTA, notably
the calcium (or magnesium) disodium salt, and the plain disodium
salt. For example, acute lead poisoning can be managed with Calcium
(or Magnesium) disodium EDTA. Acute calcium excess (often due
to parathyroid tumors, or cancer) is a medical emergency and can
be managed with judicious use of disodium EDTA. This latter agent
is quite dangerous if misused, since the serum calcium can plummet
and cause death.

Some practitioners believe that they can use Magnesium Disodium
EDTA or Disodium EDTA for allegedly removing calcium from atheromatous
plaques which line diseased arteries. Atheromata(pl. of atheroma)
are pathological collections of cells deep in the walls of arteries
which contain various forms of cholesterol. Occasionally, some
of these atheromata calcify. The "chelation therapists"
mistakenly believe that treatment with Magnesium Disodium EDTA
will remove this calcium and remove the atheromata. This belief
is unsupported by scientific theory, scientific fact, and practical
experience. A number of reviews on the topic of chelation therapy
for treating atherosclerosis (the presence of atheromata) in the
lining of arteries of major importance (aorta, coronary arteries,
and major arteries to the extremities) has shown that this therapy
is not only ineffective, but may also cause damage to the walls
of arteries and actually cause atheromata to appear. The use of
any form of EDTA for treatment of atheromata or atherosclerosis
is not approved by the U.S. FDA.

At the very best, even the proponents of chelation therapy
for atherosclerosis therapy admit that this concept is experimental.
So why is it widely advertised and promoted to the elderly?

The idea that EDTA chelation would remove calcium from atheromata
is not supported by science. First, most atheromata are not calcified.
Second, even with theoretical "success" of the treatment
for calcium removal from atheromata, biochemists have shown that
the amounts that could be removed are miniscule and irrelevant
to the disease process.

Where chelation therapy advocates have suggested any success
it has been with the ability of people with severe peripheral
vascular disease of the legs to improve their walking distances
slightly after therapy. Even these claims are controversial, and
there are data to suggest that these claims, largely supported
by only subjective data, are specious.

Major medical organizations and publications, including the
American Medical Association, multiple state licensing boards,
the American Heart Association, Harvard Medical School Health
Letter, and many medical scientists, have indicated that chelation
therapy with EDTA is ineffective for treating, eliminating, or
ameliorating vascular disease.

At the very best, chelation therapy with EDTA for treatment
of atheromatous cardiovascular disease, is unproven and experimental.
Yet, despite this fact, hundreds of unscrupulous practitioners
foist this on the public through active promotion. It is claimed
that 30-50 "treatments" must be done for "results"
and these cost anywhere from $100 to $150 each, paid in cash.
Virtually every health plan and Medicare do not pay for these
treatments.

I am regularly sent advertising clippings from areas of the
country with high proportions of elderly individuals which suggest
that this therapy is "an alternative to bypass" or can
"prevent" arteriosclerosis. One organization, the American
College for the Advancement of Medicine (ACAM) has consented to
stop false advertising after enforcement actions by the FTC, however,
the FTC cannot possibly engage all of the individual practitioners
who promote this idea.

Since their consent decree with the FTC, however, ACAM has
apparently developed a scheme to make it appear that their members
are participating in an "experiment" where EDTA therapy
is "tested" "clinically". This alleged "study"
has some of the trappings of a clinical trial, but none of the
substance. It appears to be, in my opinion, a pseudoscientific
babble of imprecise, unclear activities for its members to present
to unsuspecting, often elderly patients who have real cardiovascular
diseases. I have personally reviewed multiple cases of patients
who were directed away from potentially life-saving, or life-prolonging,
conventional, evidence-supported treatments for cardiovascular
disease to chelation therapy which provided no benefit other than
to enrich the practitioner who promoted and performed it. I have
personally seen several patients maimed and several deaths by
such careless practitioners.

Chelation therapy is only one of many such areas of illegitimate
human experimentation. I have seen the elderly (and others) regularly
victimized in schemes for "cancer cures", treating Amyotrophic
Lateral Sclerosis, alleged heavy metal poisoning, heart disease,
and neurodegenerative disorders. The since delicensed Colorado
dentist, Hal Huggins, emptied the bank accounts of an elderly
Kansas farm couple after convincing them that he could treat the
wife's breast cancer and her husband's ALS. The husband nearly
died during treatment when he aspirated unnecessary pills which
were to allegedly "detoxify" him from his dental fillings.
The wife wasted away after her teeth were removed inappropriately.
Therapy which may have cured her was postponed. And I can give
you more examples of the "dental amalgam scam" which
are more egregious.

For a number of rather transparent reasons--largely greed,
basic incompetence in "standard practices", and uncontrolled
ego--some practitioners cross the line between proper and improper
behavior. Some common excuses that are offered are: "I am
a pioneer and way ahead of the rest of the profession.",
"I discovered the "cure" and am the only one who
has it.", " There is a plot by big medicine and others
to keep this simple therapy away from you since "they"
would stand to lose millions if it got out thatÖ..".
All of these ring hollow to those who know their art/science,
but can be appealing to those who place high trust on their practitioners
and are also desperate, unsuspecting, or have impaired functioning.
Catching and stopping these "thieves of the professions"
is a task often left to the licensing boards at the state level.
However, their crimes typically transcend the mandates of the
boards and extend into areas of federal jurisdiction. These crimes
cross state borders; use telephones, modems, the Internet, and
the mails they also typically may involve money laundering and
hiding assets via "off-shore accounts", and often violate
rules of federal reimbursement and entitlement programs.

Prosecuting these "pariahs of the professions" takes
years, large budgets, and persistence. Most regulatory boards
and state prosecutors turn over at such rates that merely completing
an investigation takes several generations. The misbehaving practitioners
often have huge war chests, as they have enriched themselves on
the public. These often dwarf the meager budgets of state prosecutors.
Affording expert witnesses, collecting information, and successfully
prosecuting a meritorious case are extremely difficult. Even then,
the regulatory board can often not recover its costs of such a
prosecution, fine the offender, or mandate restitution in most
states. The smaller states can barely get to the investigation
stage, since the entire budget of the board comes only from licensing
fees, and must cover staff salaries, licensing activities, travel,
rent, and even the telephones. There is often little left over
for enforcement.

We need model legislation to tighten the laws against predatory
practitioners. We also need to help the smaller states overcome
the problems they face in being unable to afford to enforce the
rules to protect the public. We also need to put "teeth"
into the punishment for offenses. Too often the guilty get a slap
on the wrist, write off the cost of their defense as a cost of
doing business, and go right back to bilking the public.

Hype, More Problems with Enforcement, and Mass Marketing--
the Uneven Playing Field

Most doctors are very desirable advertising targets. We prescribe
tens of thousands of dollars worth of laboratory tests, a similar
value of radiographs, and hundreds of thousands of dollars worth
of pharmaceuticals each year. Obviously we get a considerable
amount of attention paid to attract where our eyeballs gaze. Some
time ago I received, in the mail, what I would call a "throw-away"
journal. Those of us in the medical field are quite familiar with
these. They are unsolicited publications that look like magazines
but are thinly disguised to appear as medical journals. Usually
they are compilations of practical tidbits and a few unusual cases.
Occasionally they contain a reasonable review. They are not cutting
edge. What they do contain are lots of advertisements for those
things we doctors prescribe.

But this "throw-away journal" was different. It was
called the "Journal of Longevity" and it was targeted
at the general public. The segment of the public it was targeted
for was obviously "older".

You know what I mean by that expression. Those of us who find
grey hairs, but would like to think they are something else, and
then begin to count them. Those of us who get mailings from the
AARP, soliciting membership. Those of us who look at the obituary
pages in the newspaper each day to see if anyone we knew has departed
our midst. Those of us who look ahead, do a little math, and wonder
whether we have more days left ahead of us compared to the number
we have experienced already.

The "Journal of Longevity" that I received did not
come from a medical mailing list. It came from a mailing list
targeted at people over 50. I use a distinctive coding system
to track the origin of mail, and this one came from a source that
I knew had access to my age and demographics.

The "Journal of Longevity" fits an image of what
I would describe as very "slick" and very targeted.
It was not a "journal" at all, but a carefully constructed
advertisement for products, made to look as if it were an authoritative
medical journal. The "articles" were each only a few
pages long, and had very smooth, colorful graphics, pleasant photographs,
and very "interesting" titles.

Some recent articles were: "The Key to Keeping and Renewing
the Body's Energy", "Are Stem Cells the Answer to Blood
Sugar Problems?", "Why 60% of Men Over 40 Have Sexual
Problems", "'Blended' Sexual Cocktail--A Shield Against
Aging?" and "Solution to Postmenopausal Difficulties
Found." The authors of these articles all appeared to have
professional degrees but had credentials such as: "has given
numerous TV and radio interviews", "is a gastroenterologist
with a successful private practice", and "is the author
of several booksÖBlessed with an abundance of energy and
expertise, he jockeys between his medical centers in Brooklyn
and Ö..his radio showÖ..in Manhattan." The photographs
in the articles appear to be obviously staged with colorful liquids
in laboratory bottles, a brand new lab coat on the person gazing
into a brand new microscope, or a hospital operating room. The
"references" included a number of medical journal articles
often from ten to twenty years ago from obscure sources, or which
were impossible to source; such as listing the Reuters News Service
Web site without any specific date or heading.

Each article had a not-so-hidden message. There was some "food
supplement" or "herb" sold as a food supplement
that seemed to be "important" to the topic of the article,
and, you guessed it, that material just happened to be sold by
Gero Vita International.

The "Journal of Longevity" is produced by "Health
Quest Publications of Reno, NV" which is owned by G.B. Data
Systems, Inc. According to the Secretary of State of California,
G.B. Data Systems has corporate offices at 521 Washington Blvd.,
Suite 420, in Marina Del Rey, CA 90292. G.B. Data Systems is listed
as a part of Gero Vita International and is directed by A. Glenn
Baswell (Florida Department of State, Division of Corporations).

A Web Site on diet fraud
has an article on Mr. Braswell and Gero Vita International entitled
"Gero Vita International & Glenn Braswell Scam the World
from Toronto Mailboxes Etc. Location." This posting states
the "address" for Gero Vita International is really
a Mail Boxes Etc. outlet at 4936 Yonge Street in Toronto. There
were links at this site to articles about a dubious pardon for
Mr. Braswell (U.S. News and World Report), an investigation in
progress regarding tax evasion, and references to ties with major
politicians, including activities during the last presidential
campaign. The Post article indicated that the George W. Bush campaign
and the Florida Republican Party returned $250,000 of Braswell's
contributions. One area of interest was a reportedly doctored
letter of endorsement of alternative medicine under Florida Governor
Jeb Bush's byline in the "Journal of Longevity." Mysteriously,
this letter does not appear in the "Journal
of Longevity" archives for the issue in which it appeared
(July 2000).

The "Washington Post" (February 6, 2001) highlighted
Mr. Braswell's 1983 felony convictions for fraud, perjury, and
tax evasion while discussing the pardon granted him by former
President Clinton. This same article quoted Stephen Barrett, M.D.
of Quackwatch, Inc. who said about Braswell, he "has probably
managed to sell more health-related products with misleading claims
than anyone else in the history of the world. His gross intake
has very likely been over a billion dollars." "Consumer
Reports" was quoted in 1998 on Gero Vita, "We see a
lot of misleading marketing, but what spews out of Gero Vita Industries
rivals the worst". "Consumer Reports" referred
to the publications of Gero Vita as "masquerading as science.
[Their] booklets cite actual studies, but twist the findings to
support the company's own unsubstantiated claims."

Recently highlighted on the website of Gero
Vita International were: Florimin -- a prebiotic formula
to strengthen body (sic) against superbugs, Heart Shield--safeguard
your heart, Testerex -- Yohimbe and Muira Puama for sexual
enhancement, and DentaZyme -- powerful enzyme spray for
healthy gums. Of note is the fact that these products had accompanying
"literature" from the "Journal of Longevity".

I regularly read the medical literature and have taught at
three major medical schools. The article in the "Journal
of Longevity" by "the gastroenterologist with the successful
private practice" suggests that there is an "imbalance
of bacteria in the intestines" and that "researchers"
(who are, of course, unnamed), have formulated a "prebiotic
supplement" rich in "biologically active friendly flora
and a special plant fiber". This article calls a "prebiotic"
a "colonic" nutrient. I can tell you as a cellular biologist
and physician that this is pure nonsense. The human colon functions
primarily as a place where water is absorbed from the material
within. That material has already been digested and its nutrients
have been absorbed in the upper portions of the gastrointestinal
tract. Beyond water absorption, the colon is mostly a conduit
for waste material. Nowhere on the Gero Vita website could I find
a list of ingredients in the "prebiotic" Florimin. I
went to its on-line direct assistance and the person who answered,
"David", could not give me a list of ingredients. I
even sent an e-mail to its customer support address without success.

I next went to explore "DentaZyme" a spray which
purportedly is "potent enough to inhibit oral bacteria from
forming" and will "protect" my gums and teeth,
although it doesn't say from what. It is implied that "DentaZyme"
is for stopping poor oral hygiene, and that "this problem
is a primary cause of respiratory illness as well as heart and
gastrointestinal problems". This is patently false. I quote
directly from the Gero Vita Web site:

Poor oral hygiene leads to far more serious problems than
cavities and gum disease. It's one of the primary causes behind
such conditions as respiratory illnesses as well as heart and
gastrointestinal problems. DentaZyme is one of the first oral
sprays potent enough to inhibit oral bacteria from forming. It
not only protects your gums and teeth, but it also helps deter
harmful bacteria from invading your vital organs. And, it comes
in a convenient, easy-to-use oral spray that fits in your purse
or pocket.

It is extremely difficult for enforcement agencies to deal
with "supplement chameleons" such as Gero Vita. New
"products" appear in the blink of an eye. What little
information is given to the public can change daily and appears
in multiple forms--print, direct mailing, and the Internet. The
company appears to be a series of companies but is really one
business, akin to a set of nesting wooden dolls, where each can
hide within another. It appears in multiple guises in multiple
places, even in different countries.

I am neither an attorney nor a law officer. I am merely a doctor.
What I have seen shows me apparently deliberate attempts to mislead
the public into buying products with information that is factually
incorrect, misleading, and deceptive. Gero Vita is only one of
many such companies, but is among the largest.

Since DSHEA seems to allow virtually anything to be called
a "supplement", claims of benefit to humans can be attached
to materials which are anything but true foods or nutritional
supplements. Even then, the "claims" are, in my opinion,
far beyond what Congress ever intended or has permitted for these
items.

How can regulatory and law enforcement agencies effectively
deal with this onslaught of "supplements"? Do they have
the tools to be able to stop false claims and protect the public?
Are they playing on an even playing field? I would answer, no.

One might say that Gero Vita/G.B. Data Systems/ "Journal
of Longevity", etc. are not breaking any law, and are merely
"in business". They sell to people who willingly buy
their products. If their literature and hype are, well, a little
"aggressive", their main defense would be "let
the buyer beware". The data would suggest that this is not
merely a simple story of a simple company that is entirely within
the law. Make no mistake, this is a well-oiled Goliath that has
reached to the highest points of our government to keep the cash
rolling in and the snake oil rolling out. Where are the data to
show their claims are supported? Where are protections the public
rightly expects? Are the regulators trying to wrestle with Goliath
with one proverbial leg cut off and one proverbial hand tied behind
their back?

For many reasons that are self-evident, enforcement actions
against such a company as Gero Vita are difficult. To be effective,
regulators must be able to act at speeds equal to the target regulatee.
They must also have the muscle and manpower. They must also have
the resources to devote to such a task and still carry on their
other duties. It is obvious that multiple agencies must be involved
in working on the problem: FDA, FTC, FBI, US Postal, just to name
a few. The problem reaches into every state and multiple foreign
countries. There are laws on the books to deal with these crimes,
however, there appears to be a distinct lack of enforcement. As
just once example, Congress needs to investigate why the US Postal
Service has not been very active over the last decade in prosecuting
false advertising that is promulgated via the mail.

To deal with problems such as this one, we need to have collaboration,
cooperation and condensation of effort to match the targets. But
we need even more. We need a strategy and a plan, not just to
confront this problem, but to prevent it at its source. We need
a serious reappraisal of DSHEA to allow us to stop the fleecing
of the public and the promotion of nonsense that would suggest
that simple "food supplements" will make us young, improve
our sex lives, give us energy, and reverse biology.

I urge the Committee to also consider ways to improve the enforcement
abilities of the FTC and FDA, which are the lead federal agencies
responsible for monitoring promotion and use of therapies and
drugs. Currently these agencies are understaffed in relation to
the volume of illegitimate activity to the direct detriment of
the public. Since practitioners are licensed by individual states,
some mechanism must be found to assist the states in their enforcement
activities. The abilities of state licensing boards to deal with
illegitimate therapies and the practitioners who promote them
are overwhelmed by the size of this problem. These agencies are
typically funded only by licensing fees and have many other duties
to perform. Practitioners can, and do, market services across
state lines. A mechanism must be found to address this problem
without interfering with powers left to the states by our Constitution.

I would further assert that there is a need for federal/state
task forces to deal with these problems as they transcend the
mandates of any one entity. Effective strategies need to be put
in place to act at the preventive level. A good start would be
the convening of meetings among state licensing boards, state
investigating agencies, state prosecuting agencies, FTC, FDA,
FBI, US Postal, and other interested parties to begin a discussion
of how to attack this significant and growing problem. Millions
if not billions of dollars are scammed each year from the public.
As mentioned earlier, this form of health fraud also causes considerable
death and disability, the burden of which often falls on the federal
government through Medicare and other entitlement programs. These
are crimes against all of us, since society-at-large is typically
the resource that has to repair the damage that these criminals
do. They truly steal from us all.

Some other areas where Congress can act easily with little
cost and significant results are:

To assist the Mexican Government in closing illegitimate
cross-border clinics which offer illegal therapies and treatments,
often by unlicensed providers. For example, recent raids in Baja,
California closed several illegal clinics, including one run
by Hulda Clark, who was mentioned earlier. However, only a small
number of operations was included in this sweep. There are many,
many more similar "clinics" which appear to have been
set up to evade our laws. By closing such operations which often
operate on both sides of the border, with mail drops, "800"
telephone numbers, and referral services, we have the opportunity
to solve problems for us and our neighbor to the south. Similarly,
improved collaboration with the Canadian authorities could help
put an end to Toronto maildrops and other cross border activities
which allow fraudsters to elude regulators and prey on the public
of both nations.

To require any company that engages in multiple level marketing
(MLM) disclose performance results to any prospective agent before
they "sign up". MLM schemes are common vehicles to
purvey worthless "dietary", "nutritional"
and "food" supplements. Full disclosure of the lack
of efficacy of the products and the meager chances of financial
rewards may dispatch the MLM menace once and for all.

To develop enabling legislation to allow States' attorneys
general to get nationwide injunctions against sales and distribution
of illegitimate and falsely advertised products. The States'
attorneys general would acts as deputies of, and in concert with,
federal agencies such as the FTC, FDA and other agencies which
have mandates for consumer protection. Perpetrators of fraud
and other schemes can easily shift operations from one state
to another, disabling and/or confounding the ability of state
authorities to act to protect the public. Enabling legislation
would close these escape routes, and add depth and potency to
the existing federal resources without added cost but with considerable
benefit.

Summary

I propose that Congress develop a plan to expeditiously deal
with the problems I have outlined. We cannot regulate effectively
when it takes from five to ten years to address a problem. Within
a few years the problem has likely grown, moved, and metamorphosed
itself confounding any attempts at administrative action. The
landscape changes quickly and the thieves are highly mobile. Nutrition
scams and the other abuses I outlined above have simply gone on
for too long. This very Senate Committee determined in 1983 that
"quackery and medical related frauds" are number One
of the ten "most harmful frauds directed against the elderly."
It would appear that we have come a long way since 1983, but in
the wrong direction.

We need to convene an interagency task force to deal with these
issues, and keep it active until the message is sent that we will
not tolerate abuses such as I have reported above. We must streamline
the process of prosecution, while still protecting the rights
of the accused. More importantly, we must also protect the rights
of the public to receive adequate, appropriate, and scientifically
valid health care. We must level the playing field so that the
perpetrators no longer have an unfair advantage over the regulatory
agencies. We must provide resources for quick and effective action,
make sure reparations are made, and make the penalties severe
enough so these crimes will not pay.

More than anything we must marshal our resources to begin discussions
on how to keep science and evidence as the framework of our medical
system. We need a plan, a timetable, and designated leadership
to make this happen. The cost of not acting is too great. We don't
need more government to do this. We need to redirect what we have
to accomplish these goals.

Consumer advocacy groups, such as the National Council Against
Health Fraud, Inc., stand ready to work with all levels of government,
and any other interested parties, to address the problems I have
outlined, and to help keep our health care system scientific,
effective, and the best in the World.